U.S. patent number 8,388,687 [Application Number 13/072,511] was granted by the patent office on 2013-03-05 for interbody device insertion systems and methods.
This patent grant is currently assigned to Flexuspine, Inc.. The grantee listed for this patent is Jonathan A. Gimbel, Scott Koysh, Michael S. Schular, Erik J. Wagner. Invention is credited to Jonathan A. Gimbel, Scott Koysh, Michael S. Schular, Erik J. Wagner.
United States Patent |
8,388,687 |
Gimbel , et al. |
March 5, 2013 |
Interbody device insertion systems and methods
Abstract
Provided is a system for implanting an interbody device into a
disc space located between a first and second vertebra includes a
guide frame including a guide member having an opening. The system
further includes an implant trial including an elongated body and a
base plate coupled to the elongated body. The elongated body of the
implant trial is releasably coupled to the guide member of the
guide frame during use such that the opening guides longitudinal
movement of the implant trial relative to the guide frame. The
system still further includes a dilator operatively coupled to the
elongated body during use for distracting the disc space. The
system still further includes an insertion instrument including an
elongated body and an insertion member coupled to the elongated
body. The elongated body of the insertion instrument is releasably
coupled to the guide member of the guide frame during use such that
the opening guides longitudinal movement of the insertion
instrument relative to the guide frame. The insertion member is
releasably coupled to at least a portion of the interbody device
during use.
Inventors: |
Gimbel; Jonathan A.
(Murrysville, PA), Schular; Michael S. (Pittsburgh, PA),
Wagner; Erik J. (Austin, TX), Koysh; Scott (Carnegie,
PA) |
Applicant: |
Name |
City |
State |
Country |
Type |
Gimbel; Jonathan A.
Schular; Michael S.
Wagner; Erik J.
Koysh; Scott |
Murrysville
Pittsburgh
Austin
Carnegie |
PA
PA
TX
PA |
US
US
US
US |
|
|
Assignee: |
Flexuspine, Inc. (Pittsburgh,
PA)
|
Family
ID: |
46877996 |
Appl.
No.: |
13/072,511 |
Filed: |
March 25, 2011 |
Prior Publication Data
|
|
|
|
Document
Identifier |
Publication Date |
|
US 20120245689 A1 |
Sep 27, 2012 |
|
Current U.S.
Class: |
623/17.16;
606/99 |
Current CPC
Class: |
A61F
2/4405 (20130101); A61F 2/4684 (20130101); A61F
2/4611 (20130101); A61F 2/4425 (20130101); A61F
2002/30393 (20130101); A61F 2002/443 (20130101); A61F
2002/30392 (20130101); A61F 2002/3082 (20130101); A61F
2310/00017 (20130101); A61F 2310/00023 (20130101); A61F
2002/30878 (20130101); A61F 2002/4687 (20130101); A61F
2002/30604 (20130101); A61F 2002/30079 (20130101); A61F
2002/30884 (20130101); A61F 2002/30579 (20130101); A61F
2002/4658 (20130101); A61F 2002/30563 (20130101); A61F
2/30767 (20130101); A61F 2002/30387 (20130101); A61F
2002/4628 (20130101); A61F 2002/30904 (20130101); A61F
2310/00958 (20130101); A61F 2002/30825 (20130101); A61F
2002/30617 (20130101); A61F 2002/30624 (20130101); A61F
2002/4629 (20130101); A61F 2002/30823 (20130101); A61F
2002/448 (20130101); A61F 2002/3008 (20130101); A61F
2250/0098 (20130101); A61F 2310/00976 (20130101); A61B
17/702 (20130101); A61F 2002/30594 (20130101); A61F
2002/30841 (20130101); A61F 2220/0025 (20130101); A61F
2002/30616 (20130101); A61F 2002/30492 (20130101); A61F
2002/30639 (20130101) |
Current International
Class: |
A61F
2/44 (20060101) |
Field of
Search: |
;623/17.11-17.16
;606/104,90,99,246,247,249,86A |
References Cited
[Referenced By]
U.S. Patent Documents
Foreign Patent Documents
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2005067824 |
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Jul 2005 |
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WO |
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2005070349 |
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Aug 2005 |
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WO |
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2005117725 |
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Dec 2005 |
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WO |
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Other References
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mailed May 4, 2012. cited by applicant .
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mailed Mar. 23, 2012. cited by applicant .
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11/371,376, mailed Mar. 23, 2012. cited by applicant .
U. S. P.T. O. Notice of Allowance for U.S. Appl. No. 11/975,919,
mailed May 11, 2012. cited by applicant .
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13/306,535, mailed May 24, 2012. cited by applicant .
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11/345,602, mailed Mar. 5, 2012. cited by applicant .
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171.8-2310 mailed on Feb. 13, 2012. cited by applicant .
J.P. Notice of Reason for Refusal for Japanese Application No.
2009-546510 mailed on Mar. 6, 2012. cited by applicant .
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10/634,950, mailed Dec. 1, 2005. cited by applicant .
U. S. P. T. O. Non-Final Office Action for U.S. Appl. No.
11/655,724, mailed Feb. 17, 2012. cited by applicant .
U. S. P.T. O. Notice of Allowance for U.S. Appl. No. 11/975,918,
mailed Jan. 19, 2012. cited by applicant .
U. S. P.T. O. Notice of Allowance for U.S. Appl. No. 11/975,917,
mailed Feb. 1, 2012. cited by applicant .
U. S. P.T. O. Final Office Action for U.S. Appl. No. 11/975,919,
mailed Jan. 27, 2012. cited by applicant .
U. S. P.T. O. Final Office Action for U.S. Appl. No. 11/134,091,
mailed Feb. 10, 2012. cited by applicant .
U. S. P.T. O. Notice of Allowance for U.S. Appl. No. 11/134,082,
mailed Jan. 11, 2012. cited by applicant .
U. S. P.T. O. Advisory Action for U.S. Appl. No. 11/134,055, mailed
Feb. 15, 2012. cited by applicant .
J.P. Notice of Reason for Refusal for Japanese Application No.
2008-558536 mailed Jan. 10, 2012. English translation provided by
foreign associate. cited by applicant .
U.S.P.T.O. Final Office Action for U.S. Appl. No. 11/371,376,
mailed Oct. 16, 2012. cited by applicant .
U.S.P.T.O. Notice of Allowance for U.S. Appl. No. 11/655,724,
mailed Oct. 4, 2012. cited by applicant .
U.S.P.T.O. Non-Final Office Action for U.S. Appl. No. 11/134,055,
mailed Nov. 8, 2012. cited by applicant .
E.P.O. Communication Pursuant to Article 94(3) for European
Application No. 07 758 171.8-2310 mailed on Oct. 11, 2012. cited by
applicant.
|
Primary Examiner: Philogene; Pedro
Attorney, Agent or Firm: Meyertons, Hood, Kivlin, Kowert
& Goetzel, P.C. Meyertons; Eric B.
Claims
What is claimed is:
1. A system for implanting interbody devices into a disc space
located between a first vertebrae and a second vertebrae,
comprising: a guide frame comprising: a first guide member
configured to guide longitudinal advancement of a first implant
trial and a first insertion instrument in a first longitudinal
direction during use; and a second guide member configured to guide
longitudinal advancement of a second implant trial and a first
insertion instrument in a second longitudinal direction angled
relative to the first longitudinal direction during use; the first
implant trial, comprising: a first elongated body configured to
couple to the first guide member of the guide frame during use; and
a first base plate disposed at a proximal end of the first elongate
body; the second implant trial, comprising: a second elongated body
configured to couple to the second guide member of the guide frame
during use; and a second base plate disposed at a proximal end of
the second elongate body; a dilator configured to disposed into at
least one of the first and second implant trials to provide for
distraction of the implant trial during use; a first insertion
instrument comprising an elongated body configured to couple to the
first guide member of the guide frame during use, wherein a
proximal end of the first insertion instrument is configured to
couple to a first interbody device during use; and a second
insertion instrument comprising an elongated body configured to
couple to the second guide member of the guide frame during use,
wherein a proximal end of the second insertion instrument is
configured to couple to a second interbody device during use.
2. The system of claim 1, wherein the first and second longitudinal
directions are at an angled relative to one another at an angle of
about 20.degree. to 30.degree..
3. The system of claim 1, wherein the first and second longitudinal
directions are at an angled relative to one another at an angle of
about 24.degree..
4. The system of claim 1, wherein the first guide member comprises
a first longitudinal slot and wherein the second guide member
comprises a second longitudinal slot angled relative to the first
longitudinal slot.
5. The system of claim 1, wherein longitudinal advancement of the
first and second implant trials in a proximal longitudinal
direction is configured to dispose the first and second base plates
within the disc space during use.
6. The system of claim 5, wherein the dialator is configured to be
disposed within at least one of the first or second base plates
within the disc space during use.
7. The system of claim 1, wherein longitudinal advancement of the
first and second insertion instruments in a proximal longitudinal
direction is configured to dispose the first and second interbody
device within the disc space during use.
8. A system for implanting interbody devices into a disc space
located between a first vertebrae and a second vertebrae,
comprising: a first implant trial comprising a first base plate
configured to be inserted into the disc space; a second implant
trial comprising a second base plate configured to be inserted into
the disc space, wherein the first base plate is configured to be
inserted into the disc space at a first given position relative to
the second base plate; a first insertion instrument configured to
couple to a first intervertebral device configured to be inserted
into the disc space; a second insertion instrument configured to
couple to a second intervertebral device configured to be inserted
into the disc space at a second given position relative to the
second base plate; and a guide frame configured to couple to the
first and second implant trials during use and to couple to the
first and second insertion instruments during use, wherein the
guide frame is configured to position the first and second implant
trials relative to one another such the first base plate is
disposed within the disc space in first given position relative to
the second base plate during use, and wherein the guide frame is
configured to position the first and second insertion instruments
relative to one another such the first intervertebral device is
disposed with the disc space in the second given position relative
to the second intervertebral device.
9. The system of claim 8, wherein first given position is
substantially the same as the second given position.
10. The system of claim 8, wherein the first given position
comprises the first and second base plates angled relative to one
another at an angle of about 20.degree. to 30.degree. and wherein
the second given position comprises the first and second interbody
devices angled relative to one another at an angle of about
20.degree. to 30.degree..
11. The system of claim 8, wherein the guide frame is configured to
guide longitudinal advancement of the first and second implant
trials and the first and second insertion instruments.
Description
BACKGROUND
1. Field of the Invention
Embodiments of the invention generally relate to functional spinal
implant assemblies for insertion into an intervertebral space
between adjacent vertebrae of a human spine. More specifically,
embodiments relate to methods of using and installing interbody
devices.
2. Description of Related Art
The human spine is a complex mechanical structure including
alternating bony vertebrae and fibrocartilaginous discs that are
connected by strong ligaments and supported by musculature that
extends from the skull to the pelvis and provides axial support to
the body. The intervertebral discs provide mechanical cushion
between adjacent vertebral segments of the spinal column and
generally include two basic components: the nucleus pulposus and
the annulus fibrosis. The intervertebral discs are positioned
between two vertebral end plates. The annulus fibrosis forms the
perimeter of the disc and is a tough outer ring that binds adjacent
vertebrae together. The end plates are made of thin cartilage
overlying a thin layer of hard cortical bone that attaches to the
spongy, cancellous bone of a vertebra. The vertebrae generally
include a vertebral foramen bounded by the anterior vertebral body
and the neural arch, which consists of two pedicles that are united
posteriorly by the laminae. The spinous and transverse processes
protrude from the neural arch. The superior and inferior articular
facets lie at the root of the transverse process.
The spine is a flexible structure capable of a high degree of
curvature and twist in nearly every direction. The motion segment
or functional spinal unit (FSU) is the basic motion unit of the
lumbar spine. The anterior elements of the FSU include the
vertebral bodies, the intervertebral disc, and the connecting soft
tissues and ligaments. The posterior elements of the FSU include
the bony ring created by the pedicles and lamina, the facet joints,
and the connecting soft tissues and ligaments. The facet joints are
located on both sides at the junction of superior and inferior bony
projections of the posterior elements.
The total motion of the spine results from the cumulative motion of
the individual FSUs. Each motion segment allows rotational motion
in three directions (flexion-extension, lateral bending, and axial
rotation) and translational motion in three directions
(anterior-posterior, medial-lateral, and superior-inferior). The
available motion is primarily governed by the intervertebral disc,
facet joints, and ligaments. Typical maximum amounts of lumbar
rotation are up to about 17.degree. of flexion-extension, 6.degree.
of lateral bending, and 3.degree. of axial rotation. Moderate
motions of the spine during everyday living may result in less than
10.degree. of flexion-extension.
Translation of one vertebral body with respect to an adjacent
vertebral body can be up to a few millimeters during rotation. The
quality of the motion is described by the shape of the motion
segment moment-rotation curve. The motion segment moment-rotation
curve is the rotational response of the FSU due to loading away
from the center of rotation. The moment-rotation curves are
non-linear with an initial low stiffness region, followed by a
higher stiffness region. The initial region of high flexibility,
where spinal motion is produced with less resistance to bending
moments, is typically referred to as the neutral zone. Typically,
the neutral zone ranges from 10-50% of the total range of motion.
The stiffness (Nm/deg) in the neutral zone is about 10-30% of the
high stiffness region. Alterations to the FSU caused by surgical
intervention, degeneration, acute injury, or other factors are
thought to change this non-linear behavior.
Genetic or developmental irregularities, trauma, chronic stress,
and degenerative wear can result in spinal pathologies for which
surgical intervention may be necessary. In cases of deterioration,
disease, or injury, an intervertebral disc, or a portion of the
intervertebral disc, may be removed from the human spine during a
discectomy.
After some discectomies, one or more non-dynamic intervertebral
devices may be placed in the disc space to fuse or promote fusion
of the adjacent vertebrae. During some procedures, fusion may be
combined with posterior fixation to address intervertebral disc
and/or facet problems. The fusion procedure (e.g., posterior lumbar
interbody fusion) and the posterior fixation procedure may be
performed using a posterior approach. The posterior fixation and
non-dynamic intervertebral devices may cooperate to inhibit motion
and promote bone healing. Fusing two vertebrae together results in
some loss of motion. Fusing two vertebrae together may also result
in the placement of additional stress on one or more adjacent
functional spinal units. The additional stress may cause
deterioration of an adjacent functional spinal unit that may result
in the need for an additional surgical procedure or procedures.
After some discectomies, a dynamic intervertebral device (DID) may
be placed in the disc space. The DID may allow for movement of
adjacent vertebrae coupled to the DID relative to each other. U.S.
Pat. No. 4,863,477 to Monson, which is incorporated herein by
reference, discloses a resilient dynamic device intended to replace
the resilience of a natural human spinal disc. U.S. Pat. No.
5,192,326 to Bao et al., which is incorporated herein by reference,
describes a prosthetic nucleus for replacing just the nucleus
portion of a human spinal disc. U.S. Patent Application Publication
No. 2005/0021144 to Malberg et al., which is incorporated herein by
reference, describes an expandable spinal implant. Allowing for
movement of the vertebrae coupled to the disc prosthesis may
promote the distribution of stress that reduces or eliminates the
deterioration of adjacent functional spinal units.
An intervertebral device may be positioned between vertebrae using
a posterior approach, an anterior approach, a lateral approach, or
other type of approach. A challenge of positioning a device between
adjacent vertebrae using a posterior approach is that a device
large enough to contact the end plates and slightly expand the
space must be inserted through a limited space. This challenge is
often further heightened by the presence of posterior osteophytes,
which may cause "fish mouthing" of the posterior vertebral end
plates and result in very limited access to the disc. A further
challenge in degenerative disc spaces is the tendency of the disc
space to assume a lenticular shape, which may require a larger
implant than can be easily introduced without causing trauma to
adjacent nerve roots. The size of rigid devices that may safely be
introduced into the disc space is thereby limited. During some
spinal fusion procedures using a posterior approach, two implants
are inserted between the vertebrae. During some posterior
procedures, one or both facet joints between the vertebrae may be
removed to provide additional room for the insertion of a fusion
device. Removal of the facet may also allow for the removal of soft
tissue surrounding the facet (for example, the facet capsule) that
work to resist posterior distraction.
The anterior approach poses significant challenges as well. Though
the surgeon may gain very wide access to the interbody space from
the anterior approach, this approach has its own set of
complications and limitations. The retroperitoneal approach usually
requires the assistance of a surgeon skilled in dealing with the
visceral contents and the great vessels. The spine surgeon has
limited access to the nerve roots and little or no ability to
access or replace the facet joints. Complications of the anterior
approach that are approach specific include retrograde ejaculation,
ureteral injury, and great vessel injury. Injury to the great
vessels may result in massive blood loss, postoperative venous
stasis, limb loss, or death. The anterior approach is often more
difficult in patients with significant obesity and may be virtually
impossible in the face of previous retroperitoneal surgery.
Despite the difficulties of the anterior approach, the anterior
approach does allow for the wide exposure needed to place a large
device. In accessing the spine anteriorly, one of the major
structural ligaments, the anterior longitudinal ligament, must be
completely divided. A large amount of anterior annulus must also be
removed along with the entire nucleus. Once these structures have
been resected, the vertebral bodies may need to be over distracted
to place the device within the disc space and restore disc space
height. Failure to adequately tension the posterior annulus and
ligaments increases the risk of device failure and/or migration.
Yet in the process of placing these devices, the ligaments are
overstretched while the devices are forced into the disc space
under tension. Over distraction can damage the ligaments and the
nerve roots. The anterior disc replacement devices currently
available or in clinical trials may be too large to be placed
posteriorly, and may require over distraction during insertion to
allow the ligaments to hold them in position.
A facet joint or facet joints of a functional spinal unit may be
subjected to deterioration, disease or trauma that requires
surgical intervention. Disc degeneration is often coupled with
facet degeneration, so that disc replacement only may not be
sufficient treatment for a large group of patients.
Facet degeneration may be addressed using a posterior approach.
Thus a second surgical approach may be required if the disc
degeneration is treated using an anterior approach. The need to
address facet degeneration has led to the development of facet
replacement devices. Some facet replacement devices are shown in
U.S. Pat. No. 6,419,703 to Fallin et al.; U.S. Pat. No. 6,902,580
to Fallin et al.; U.S. Pat. No. 6,610,091 to Reiley; U.S. Pat. No.
6,811,567 to Reiley; and U.S. Pat. No. 6,974,478 to Reiley et al,
each of which is incorporated herein by reference. The facet
replacement devices may be used in conjunction with anterior disc
replacement devices, but the facet replacement devices are usually
not designed to provide a common center of rotation with the
anterior disc replacement devices. The use of an anterior disc
replacement device that has a fixed center of rotation contrary to
the fixed center of rotation of the facet replacement device may
restrict or diminish motion and be counterproductive to the intent
of the operation.
During some spinal stabilization procedures a posterior fixation
system may be coupled to the spine. During some procedures,
posterior fixation systems may be coupled to each side of the
spine. The posterior fixation systems may include elongated members
that are coupled to vertebrae by fasteners (e.g., hooks and
screws). One or more transverse connectors may be connected to the
posterior fixation systems to join and stabilize the posterior
fixation systems.
During some spinal stabilization procedures, dynamic posterior
stabilization systems may be used. U.S. Patent Publication Nos.
2005/0182409 to Callahan et al.; 2005/0245930 to Timm et al.; and
2006/0009768 to Ritland, each of which is incorporated herein by
reference, disclose dynamic posterior stabilization systems.
During some spinal stabilization procedures, a dynamic interbody
device or devices may be used in conjunction with one or more
dynamic posterior stabilization systems. U.S. Patent Publication
No. 2006/0247779 to Gordon et al., U.S. Patent Publication No.
2008/0234740 to Landry et al., and U.S. Patent Publication No.
2009/0105829 to Gimbel et al. each of which is incorporated herein
by reference, disclose dynamic interbody devices and dynamic
posterior stabilization systems that may be used together to
stabilize a portion of a spine.
Unfortunately, in the above described techniques, it may be
difficult to prepare an intevertabral disc space for receipt of one
or more spinal implants and it may also be difficult to accurately
place the implants and devices described above within the disc
space. For example, when placing a dynamic interbody device into
the disc space it may be required that the device is positioned
precisely realtive to the adjacent vertebra to provide for
effective operation of the implant devices during use. Moreover, in
some instances where multiple dynamic interbody devices are placed
within the disc space, it may be required that the devices are
positioned precisely realtive to one another to provide for
effective operation of the implant devices during use. Furthermore,
improper placement of devices may increase the risk of injury to
the patient, including nerve root damage during disc space
preparation and interbody device placement.
SUMMARY
Various embodiments of interbody devices and insertion methods for
installing interbody devices are described. In some embodiments,
provided is a method of implanting an interbody device into a disc
space located between a first and second vertebra including
inserting a base plate of a first implant trial into the disc
space. The method further includes inserting a base plate of a
second implant trial into the disc space, wherein the second
implant trial is coupled to the first implant trial to position the
base plate of the first implant trial relative to the base plate of
the second implant trial. The method still further includes
inserting one or more dilators into the disc space proximate the
base plates of the first or second implant trials to distract the
first and second vertebrae. The method still further includes
removing the base plate of the first implant trial and the dilators
from the disc space. The method still further includes inserting
the interbody device into the disc space in substantially the same
position as the base plate of the first implant trial.
In some embodiments, provided is a method of implanting interbody
devices into a disc space located between a first and second
vertebra including inserting a base plate of a first implant trial
to a selected location at least partially within the disc space,
the first implant trial including an elongated body and a base
plate coupled to the elongated body. The selected location includes
a selected angle with respect to the sagittal plane of the
vertebra. The method further includes inserting a first dilator
between the base plate of the first implant trial and the first or
second vertebra to distract the vertebrae. The method still further
includes coupling a first guide member of a guide frame to the
elongated body of the first implant trial, the guide frame further
including a second guide member. The first and second guide members
of the guide frame are rigidly coupled and positioned at a selected
convergent angle relative to one another. The method still further
includes coupling an elongated body of a second implant trial to
the second guide member such that a base plate of the second
implant trial is inserted at least partially within the disc space,
and such that at least a portion of the base plate of the second
implant trial abuts a portion of the base plate of the first
implant trial. The method still further includes inserting a second
dilator between the base plate of the second implant trial and the
first or second vertebra to distract the vertebrae. The method
still further includes removing the base plate of the first implant
trial and the first dilator from the disc space and uncoupling the
elongated body of the first implant trial from the first guide
member. The method still further includes, coupling an elongated
body of a first insertion instrument to the first guide member such
that a first interbody device is inserted at least partially within
the disc space in substantially the same position as the base plate
of the first implant trial, the first insertion instrument
including the elongated body and an insertion member coupled to the
elongated body, wherein the insertion member is releasably coupled
to the first interbody device. The first interbody device is
positioned within the disc space at a selected angle with respect
to the sagittal plane of the vertebra. The method still further
includes, removing the base plate of the second implant trial and
the second dilator from the disc space and uncoupling the elongated
body of the second implant trial from the second guide member. The
method still further includes, coupling an elongated body of a
second insertion instrument to the second guide member such that a
second interbody device is inserted at least partially within the
disc space in substantially the same position as the base plate of
the second implant trial, the second insertion instrument including
an elongated body and an insertion member coupled to the elongated
body, wherein the insertion member is releasably coupled to the
second interbody device. At least a portion of the second interbody
device is located at or near the first interbody device. The method
still further includes, uncoupling the first interbody device from
the insertion member of the first insertion instrument. The method
still further includes, uncoupling the second interbody device from
the insertion member of the second insertion instrument.
In some embodiments, provided is a system for implanting an
interbody device into a disc space located between a first and
second vertebra including a guide frame, the guide frame including
a guide member having an opening. The system further includes an
implant trial including an elongated body and a base plate coupled
to the elongated body. The elongated body of the implant trial is
releasably coupled to the guide member of the guide frame during
use such that the opening guides longitudinal movement of the
implant trial relative to the guide frame. The system still further
includes a dilator operatively coupled to the elongated body during
use for distracting the disc space. The system still further
includes an insertion instrument including an elongated body and an
insertion member coupled to the elongated body. The elongated body
of the insertion instrument is releasably coupled to the guide
member of the guide frame during use such that the opening guides
longitudinal movement of the insertion instrument relative to the
guide frame. The insertion member is releasably coupled to at least
a portion of the interbody device during use.
In some embodiments, provided is a system for implanting interbody
devices into a disc space located between a first and second
vertebra including a guide frame, the guide frame including a first
guide member having a first opening and a second guide member have
a second opening. The system further includes first and second
implant trials each including an elongated body and a base plate
coupled to the elongated body. The elongated bodies of the first
and second implant trials are releasably coupled to the first and
second guide members of the guide frame respectively during use
such that the openings of the first and second guide members of the
guide frame guide longitudinal movement of the first and second
implant trials respectively relative to the guide frame. The system
still further includes a dilator operatively coupled to the
elongated body of the first or second implant trial during use for
distracting the disc space. The system still further includes,
first and second insertion instruments each including an elongated
body and an insertion member coupled to the elongated body. The
elongated bodies of the first and second insertion instruments are
releasably coupled to the first and second guide members of the
guide frame respectively during use such that the openings of the
first and second guide members of the guide frame guide
longitudinal movement of the first and second insertion instruments
respectively relative to the guide frame. The insertion members of
the first and second insertion instruments are each releasably
coupled to complementary interbody devices during use.
In some embodiments, provided is a system for implanting an
interbody device into a disc space located between a first and
second vertebra, including a guide frame, the guide frame including
an insertion bridge and first and second guide members. The first
and second guide members of the guide frame are rigidly coupled to
the insertion bridge and positioned at a convergent angle relative
to one another during use. The first and second guide members of
the guide frame each include an opening, the openings including a
channel with a lateral opening. The first and second guide members
of the guide frame each include at least a first portion of a
locking mechanism. The system further includes first and second
implant trials each including an elongated body and a base plate
coupled to the elongated body. The elongated bodies of the first
and second implant trials are releasably coupled to the first and
second guide members of the guide frame respectively during use
such that the respective openings of the first and second guide
members of the guide frame guide longitudinal movement of the
implant trials relative to the guide frame. The system still
further includes, a dilator operatively coupled to the elongated
body of the first or second implant trial during use for
distracting the disc space. The system still further includes,
first and second insertion instruments each including an elongated
body and an insertion member coupled to the elongated body. The
elongated bodies of the first and second insertion instruments are
releasably coupled to the first and second guide members of the
guide frame respectively during use. The insertion members of the
first and second insertion instruments are releasably coupled to
complementary interbody devices during use.
In some embodiments, provided is a system for implanting interbody
devices into a disc space located between a first and second
vertebra including a guide frame, the guide frame including first
and second guide members. The first and second guide members of the
guide frame are rigidly coupled to one another and positioned at a
selected convergent angle relative to one another during use. The
first and second guide members of the guide frame each include
openings receiving an elongated body during use. The first and
second guide members of the guide frame each include at least a
first portion of a locking mechanism fixedly coupling the guide
frame to an elongated body during use. The system further includes
first and second implant trials each including an elongated body
and a base plate coupled to the elongated body. The elongated
bodies of the first and second implant trials are releasably
coupled to the first and second guide members of the guide frame
respectively during use such that the respective openings guide
longitudinal movement of the implant trials relative to the guide
frame. The elongated bodies are configured to advance laterally
into engagement with the openings of the first and second guide
members of the guide frame. The system further includes first and
second insertion instruments each including an elongated body and
an insertion member coupled to the elongated body. The elongated
bodies of the first and second insertion instruments are releasably
coupled to the first and second guide members of the guide frame
respectively during use. The insertion members of the first and
second insertion instruments are releasably coupled to
complementary interbody devices during use.
In some embodiments, provided is a system for implanting interbody
devices into a disc space located between a first and second
vertebra including a guide frame, the guide frame including first
and second guide members. The system further includes first and
second implant trials, the first and second implant trials each
including an elongated body. The elongated bodies of the first and
second implant trials are releasably coupled to the first and
second guide members of the guide frame respectively during use.
The first and second implant trials each further include a base
plate coupled to the elongated body. The base plate includes an
inferior and/or superior surface having a shape that is
substantially the same as the shape of an inferior and/or superior
surface of an interbody device. The system still further includes a
dilator releasably coupled to the elongated body of the first or
second implant trial during use such that, the dilator can be
uncoupled from the elongated body and replaced with another
dilator. The system still further includes first and second
insertion instruments each including an elongated body and an
insertion member coupled to the elongated body. The elongated
bodies of the first and second insertion instruments are releasably
coupled to the first and second guide members of the guide frame
respectively during use. The insertion members of the first and
second insertion instruments are releasably coupled to
complementary interbody devices during use.
In some embodiments, provided is a system for implanting interbody
devices into a disc space located between a first and second
vertebra including a guide frame including first and second guide
members. The first and second guide members of the guide frame are
rigidly coupled to one another and positioned at a selected
convergent angle relative to one another during use. The system
further includes first and second implant trials each including an
elongated body and a base plate coupled to the elongated body. The
elongated bodies of the first and second implant trials are
releasably coupled to the first and second guide members of the
guide frame respectively during use. The system still further
includes first and second dilators releasably coupled to the
respective elongated bodies of the first and second implant trials
during use such that the first and second dilators can be uncoupled
from the elongated bodies of the first and second implant trials
and replaced with another dilator. The base plates of the first and
second implant trials are coupled to the respective elongated
bodies of the first and second implant trials such that, during
use, when the elongated bodies of the first and second implant
trials are coupled to the respective first and second guide members
of the guide frame, and when the base plates of the first and
second implant trials are at least partially inserted into the disc
space, the base plates of the first and second implant trials are
positioned at a substantially equal anterior-posterior depth within
the disc space. The system still further includes first and second
insertion instruments each including an elongated body and an
insertion member coupled to the elongated body. The elongated
bodies of the first and second insertion instruments are releasably
coupled to the first and second guide members of the guide frame
respectively during use. The insertion members of the first and
second insertion instruments are releasably coupled to
complementary interbody devices during use.
In some embodiments, provided is a system for implanting interbody
devices into a disc space located between a first and second
vertebra including a guide frame, the guide frame including an
insertion bridge and first and second guide members. The first and
second guide members of the guide frame are rigidly coupled to the
insertion bridge and positioned at a selected convergent angle
relative to one another during use. The first and second guide
members of the guide frame each include an opening, the openings
including a channel with a lateral opening. The first and second
guide members of the guide frame each include a first portion of a
locking mechanism. The system further includes first and second
implant trials including an elongated body and a base plate coupled
to the elongated body. The elongated body of the first implant
trial is slidable through the opening of the first guide member and
the elongated body of the second implant trial is slidable through
the opening of the second guide member. The elongated bodies of the
first and second implant trials each include a second portion of
the locking mechanism, such that, during use, when the first and
second portions of the locking mechanism are engaged, the first and
second guide members of the guide frame are fixedly coupled to the
respective elongated bodies of the first and second implant trials
at a selected location on the elongated bodies of the first and
second implant trials. The first and second implant trials each
include a longitudinal slot. The system still further includes a
dilator operatively coupled to the elongated body of the first or
second implant trial during use for distracting the disc space. The
dilator is located in the longitudinal slot of the first or second
implant trial. The system still further includes first and second
insertion instruments including an elongated body and an insertion
member coupled to the elongated body. The elongated body of the
first insertion instrument is slidable through the opening of the
first guide member and the elongated body of the second insertion
instrument is slidable through the opening of the second guide
member. The elongated bodies of the first and second insertion
instruments each include the second portion of the locking
mechanism, such that, during use, when the first and second
portions of the locking mechanism are engaged, the first and second
guide members of the guide frame are fixedly coupled to the
respective elongated bodies of the first and second insertion
instruments at a selected location on the elongated bodies of the
first and second insertion instruments. The insertion members of
the first and second insertion instruments are releasably coupled
to respective complementary interbody devices during use.
In some embodiments, provided is an apparatus for implanting an
interbody device into a disc space located between a first and
second vertebra including a guide frame, the guide frame including
an insertion bridge and first and second guide members. The first
and second guide members of the guide frame are rigidly coupled to
the insertion bridge and positioned at a convergent angle between
about 20.degree. to 30.degree. relative to one another during use.
The first and second guide members of the guide frame each include
openings receiving an elongated body during use, the openings
including a channel with a lateral opening. The first and second
guide members of the guide frame each include at least a first
portion of a locking mechanism fixedly coupling the guide frame to
an elongated body during use.
In some embodiments, provided is an apparatus for implanting an
interbody device into a disc space located between a first and
second vertebra including an implant trial, the implant trial
including an elongated body. The implant trial further including a
base plate coupled to the elongated body during use. The base plate
includes an inferior and/or superior surface having a shape that is
substantially the same as the shape of an inferior and/or superior
surface of an interbody device. The implant trial still further
including a dilator releasably coupled to the elongated body during
use such that the dilator can be uncoupled from the elongated body
and replaced with another dilator. The implant trial still further
includes a nerve root shield coupled to the elongated body during
use. The nerve root shield includes a surface that is shaped
complementary to a surface of the first or second vertebra.
BRIEF DESCRIPTION OF THE DRAWINGS
Advantages of the present invention will become apparent to those
skilled in the art with the benefit of the following detailed
description and upon reference to the accompanying drawings in
which:
FIG. 1 is a perspective view of two dynamic interbody devices
positioned between vertebrae in accordance with one or more
embodiments of the present technique;
FIG. 2 is a rear view of the two dynamic interbody devices in
accordance with one or more embodiments of the present
technique;
FIG. 3 is a front view of a first member of a dynamic interbody
device in accordance with one or more embodiments of the present
technique;
FIG. 4 is a side view of the first member of the dynamic interbody
device in accordance with one or more embodiments of the present
technique;
FIG. 5 is a top view of the first member of the dynamic interbody
device in accordance with one or more embodiments of the present
technique;
FIG. 6 is a front view of a second member of the dynamic interbody
device in accordance with one or more embodiments of the present
technique;
FIG. 7 is a side view of the second member of the dynamic interbody
device in accordance with one or more embodiments of the present
technique;
FIG. 8 is a top view of the second member of the dynamic interbody
device in accordance with one or more embodiments of the present
technique;
FIG. 9 is a bottom view of the second member of the dynamic
interbody device in accordance with one or more embodiments of the
present technique;
FIG. 10 is a perspective view of the second member of the dynamic
interbody device in accordance with one or more embodiments of the
present technique;
FIG. 11 is a perspective view of the third member of the dynamic
interbody device in accordance with one or more embodiments of the
present technique;
FIG. 12 is a perspective view of a posterior stabilization system
in accordance with one or more embodiments of the present
technique;
FIG. 13 is a side view of a dynamic interbody device and a
posterior stabilization system coupled to vertebrae in accordance
with one or more embodiments of the present technique;
FIG. 14 is a front perspective view of an implant trial in
accordance with one or more embodiments of the present
technique;
FIG. 15 is a rear perspective view of the implant trial in
accordance with one or more embodiments of the present
technique;
FIG. 16 is a side view of a lower portion of the implant trial in
accordance with one or more embodiments of the present
technique;
FIG. 17 is a perspective view of the implant trial including a
dilator in accordance with one or more embodiments of the present
technique;
FIG. 18 is a side view of a lower portion of the implant trial
including a dilator in accordance with one or more embodiments of
the present technique;
FIG. 19 is a perspective view of a guide frame in accordance with
one or more embodiments of the present technique;
FIG. 20 is a top view of a guide member of the guide frame with a
guide release in a first position in accordance with one or more
embodiments of the present technique;
FIG. 21 is a top view of the guide member of the guide frame with a
guide release in a second position in accordance with one or more
embodiments of the present technique;
FIG. 22 is a perspective view of an insertion instrument in
accordance with one or more embodiments of the present
technique;
FIG. 23 is a perspective view of an implant trial having a base
plate inserted into a disc space between vertebrae in accordance
with one or more embodiments of the present technique;
FIG. 24 is a front view of a lower portion of the implant trial of
FIG. 23 with the base plate inserted into a disc space between
vertebrae in accordance with one or more embodiments of the present
technique;
FIG. 25 is a perspective view of an upper portion of the implant
trial of FIG. 23 depicting a dilator being coupled to the implant
trial in accordance with one or more embodiments of the present
technique;
FIG. 26 is a side view of a lower portion of the implant trial of
FIG. 23 having a base plate inserted into a disc space between
vertebrae and including a dilator in accordance with one or more
embodiments of the present technique;
FIG. 27 is a perspective view of an upper portion of the implant
trial of FIG. 23 depicting a guide member being coupled to the
implant trial in accordance with one or more embodiments of the
present technique;
FIG. 28 is a perspective view of a second implant trial being
coupled to a second guide member in accordance with one or more
embodiments of the present technique;
FIG. 29 is a front view of lower portions of the two implant trials
having respective base plates inserted into a disc space between
vertebrae in accordance with one or more embodiments of the present
technique;
FIG. 30 is a perspective view of an upper portion of the implant
trial of FIG. 23 including a drill guide in accordance with one or
more embodiments of the present technique;
FIG. 31 is a perspective view of an upper portion of the implant
trial of FIG. 23 depicting a anchor guide being inserted into the
disc space in accordance with one or more embodiments of the
present technique;
FIG. 32 is a side view of a lower portion of the implant trial of
FIG. 23 having a base plate inserted into a disc space between
vertebrae and including drill and anchor guides in accordance with
one or more embodiments of the present technique;
FIG. 33 is a perspective view of the implant trial of FIG. 23
including drill and anchor guides having a base plate inserted into
a disc space between vertebrae and coupled to a guide member in
accordance with one or more embodiments of the present
technique;
FIG. 34 is a perspective view of a top portion of an insertion
instrument being coupled to a guide member in accordance with one
or more embodiments of the present technique;
FIG. 35 is a side view of lower portion of the insertion instrument
of FIG. 34 coupled to a dynamic interbody device inserted into a
disc space between vertebrae in accordance with one or more
embodiments of the present technique;
FIG. 36 is a front view of two insertion instruments coupled to
respective dynamic interbody devices inserted into a disc space
between vertebrae in accordance with one or more embodiments of the
present technique;
FIG. 37 is a flowchart that illustrates a method of inserting a
dynamic interbody device into a disc space in accordance with one
or more embodiments of the present technique.
While the invention may be susceptible to various modifications and
alternative forms, specific embodiments thereof are shown by way of
example in the drawings and will herein be described in detail. The
drawings may not be to scale. It should be understood, however,
that the drawings and detailed description thereto are not intended
to limit the invention to the particular form disclosed, but to the
contrary, the intention is to cover all modifications, equivalents,
and alternatives falling within the spirit and scope of the present
invention as defined by the appended claims.
DETAILED DESCRIPTION
A "functional spinal unit" generally refers to a motion segment of
a spine. The functional spinal unit may include two vertebrae, an
intervertebral disc between the vertebrae, and the two facet joints
between the vertebrae. An "artificial functional spinal unit"
refers to a functional spinal unit where one or more of the
components of the functional spinal unit are replaced by implants
or devices that permit at least some motion of the spine. At least
a portion of the intervertebral disc and/or one or both of the
facet joints may be replaced by implants or devices during a spinal
stabilization procedure.
As used herein, "coupled" includes a direct or indirect joining or
touching unless expressly stated otherwise. For example, a first
member is coupled to a second member if the first member contacts
the second member, or if a third member is positioned between the
first member and the second member.
An "interbody device" generally refers to an artificial
intervertebral implant. The interbody device may replace a portion
or all of an intervertebral disc. In some embodiments, a pair of
interbody devices is installed during a spinal stabilization
procedure. In some embodiments, one or more interbody devices are
installed using a posterior approach. In other embodiments, one or
more interbody devices may be installed using an anterior approach
or other type of approach. In some embodiments, one or more
interbody devices are placed in a disc space between vertebrae, and
at least one posterior stabilization system is coupled to the
vertebrae. In some embodiments, one or more interbody devices are
placed in the disc space without coupling a posterior stabilization
system to the vertebrae.
A "fusion interbody device" generally refers to an interbody device
that facilitates fusion of adjacent vertebrae coupled to the
device. A fusion device may provide stabilization of adjacent
vertebra to at least partially inhibit movement of the vertebra to
facilitate bone growth to fuse the adjacent vertebra.
A "dynamic interbody device" generally refers to an interbody
device that allows for flexion/extension, lateral bending and/or
axial rotation of vertebrae coupled to the device.
In some embodiments, the dynamic interbody device is a bimodal
device. Bimodal refers to a device that has at least two separate
curved surfaces to accommodate flexion/extension with lateral
bending and/or axial rotation.
Dynamic interbody devices may have surfaces that contact vertebrae.
In some embodiments, a surface of the dynamic interbody device that
contacts a vertebra may include one or more anchors, protrusions,
and/or osteoconductive/osteoinductive layers or coatings. A anchor
of the dynamic interbody device may be positioned in an aperture
formed in a vertebra. The aperture may be formed in the vertebra so
that the dynamic interbody device will be positioned at a desired
location when inserted into the patient.
In some embodiments, one or more dynamic interbody devices are
installed in a disc space formed between vertebrae during a spinal
stabilization procedure. The shape and/or size of a dynamic
interbody device may depend on a number of factors including
surgical approach employed for insertion, intended position in the
spine (e.g., cervical or lumbar), and patient anatomy. As described
in U.S. Patent Publication No. 2009/0105829 to Gimbel et al.,
several sizes of interbody devices may be provided in the
instrument kit for the spinal stabilization procedure. The dynamic
interbody devices may include indicia indicating the height of the
spinal stabilization devices.
The dynamic interbody devices may allow for flexion/extension,
axial rotation, and/or lateral bending of vertebrae coupled to the
dynamic interbody device.
The dynamic interbody device may allow for coupled lateral bending
and axial rotation so that axial rotation causes some lateral
bending and lateral bending causes some axial rotation. The dynamic
interbody device may be formed so that a set amount of lateral
bending results in a set amount of axial rotation.
In some embodiments, a pair of dynamic interbody devices may be
installed between two vertebrae to establish all or a portion of a
spinal stabilization system. Each dynamic interbody device of the
pair of dynamic interbody devices may be installed using a
posterior approach.
As used herein a "dynamic posterior stabilization system" generally
refers to an apparatus that may be used to at least partially
replace or supplement a facet joint while allowing for both dynamic
resistance and at least some motion of the first vertebra to be
stabilized relative to the second vertebra to be stabilized. The
first vertebra and the second vertebra may be vertebrae of a
functional spinal unit. In some embodiments, bone fasteners of the
dynamic posterior stabilization system are secured to the first
vertebra and the second vertebra. In some embodiments, a bone
fastener of the dynamic posterior stabilization system may be
coupled to a vertebra adjacent to the vertebrae of the functional
spinal unit being stabilized. The bone fasteners may be coupled to
lamina, pedicles, and/or vertebral bodies of the vertebrae. In some
embodiments, dynamic posterior stabilization systems may be
positioned in three or more vertebrae to form a multi-level
stabilization system.
The dynamic posterior stabilization system may replace or
supplement a normal, damaged, deteriorated, defective or removed
facet joint. The dynamic posterior stabilization system may include
bone fasteners, an elongated member, and at least one bias member.
The bias member may provide little or no initial resistance to
movement of a first vertebra coupled to the system relative to a
second vertebra coupled to the system. Resistance to additional
movement of the first vertebra relative to the second vertebra may
increase. The increasing resistance provided by the bias member may
mimic the behavior of a normal functional spinal unit. The dynamic
posterior stabilization system may stabilize the vertebrae, limit
the range of motion of the first vertebra relative to the second
vertebra, and/or share a portion of the load applied to the
vertebrae. The dynamic posterior stabilization system may work in
conjunction with one or more interbody devices to provide support
provided by a natural facet. For example, a dynamic interbody
device may provide for coupled lateral bending and axial rotation
of the adjacent vertebra as well as enable flexion and extension,
while the posterior stabilization system provides for
controlled/dampened lateral bending, axial rotation, flexion and
extension of the adjacent vertebra.
In some embodiments, dynamic interbody devices and dynamic
posterior stabilization systems may be made of non-magnetic,
radiolucent materials to allow unrestricted intra-operative and
post-operative imaging. Certain material may interfere with x-ray
and/or magnetic imaging. Magnetic materials may interfere with
magnetic imaging techniques. Most non-magnetic stainless steels and
cobalt chrome contain enough iron and/or nickel so that both
magnetic imaging and x-ray imaging techniques are adversely
affected. Other materials, such as titanium and some titanium
alloys, are substantially iron free. Such materials may be used
when magnetic imaging techniques are to be used, but such materials
are often radio-opaque and sub-optimal for x-ray imagining
techniques. Many ceramics and polymers are radiolucent and may be
used with both magnetic imaging techniques and x-ray imaging
techniques. The dynamic interbody devices and/or the dynamic
posterior stabilization systems may include coatings and/or markers
that indicate the positions of the devices and/or systems during
operative and/or post-operative imaging.
In some embodiments, two cooperative interbody devices (e.g.,
fusion or dynamic interbody devices) may be positioned in a disc
space between two vertebrae during a spinal stabilization
procedure. FIG. 1 is a perspective view of two interbody devices
100', 100'' positioned between vertebrae 102, 104 in accordance
with one or more embodiments of the present technique. In the
illustrated embodiment, interbody devices 100', 100'' includes
dynamic interbody devices. Dynamic interbody devices 100', 100''
may be implanted using a posterior approach. Anterior ends and/or
posterior ends of dynamic interbody devices 100', 100'' may be
positioned near the edge of the endplates of vertebrae 102, 104 so
that the dynamic interbody devices abut strong, supportive bone of
the vertebrae to be stabilized. Dynamic interbody devices 100',
100'' may be bilateral devices with coupled axial rotation and
lateral bending. Although several embodiments are discussed with
regard to dynamic interbody devices, the same or similar techniques
may be employed for inserting other types of implants, such as
fusion interbody devices (e.g, spinal fusion implants). For
example, interbody devices 100' and 100'' may include fusion
interbody devices in place of dynamic interbody devices described
herein.
FIG. 2 is a rear view of dynamic interbody devices 100', 100'' in
accordance with one or more embodiments of the present technique.
Each dynamic interbody device 100' or 100'' may include first
member 106, second member 108 and third member 110. First members
106 may be coupled to second members 108 so that dynamic interbody
devices 100', 100'' accommodate lateral bending and axial rotation
of vertebrae coupled to the dynamic interbody devices. In some
embodiments, dynamic interbody devices 100', 100'' couple lateral
bending and axial motion together so that lateral bending motion
causes axial rotation, and axial rotation causes lateral bending.
Third members 110 may be coupled to second members 108 so that
dynamic interbody device 100', 100'' accommodate flexion and
extension of vertebrae coupled to the dynamic interbody device.
Dynamic interbody devices 100', 100'' are shown in positions of
neutral lateral bending, neutral axial rotation and maximum flexion
in FIG. 2. In some embodiments, the first members are coupled to
the second members to allow for lateral bending without coupled
axial rotation and/or axial rotation without coupled lateral
bending.
In some embodiments, first member 106 of dynamic interbody device
100' may be substantially a mirror image first member 106 of
dynamic interbody device 100'', and third member 110 of dynamic
interbody device 100' may be substantially a minor image of third
member 110 of dynamic interbody device 100''. In other embodiments,
the first member of dynamic interbody device 100' may have a shape
that is different than the mirror image of the first member of
dynamic interbody device 100'' and/or the third member of dynamic
interbody device 100' may have a shape that is different than the
minor image of the third member of dynamic interbody device
100''.
Second member 108 of dynamic interbody device 100' may be
substantially the minor image of second member 108 of dynamic
interbody device 100'' with the exception of second member 108 of
dynamic interbody device 100' having portion 112 (e.g., a
protrusion) that engages a complementary portion 114 (e.g., a
recess) of second member 108 of dynamic interbody device 100'' to
join dynamic interbody device 100' to dynamic interbody device
100'' when the dynamic interbody devices are positioned between
vertebrae. In other embodiments, first member 106 of dynamic
interbody device 100' has a portion (e.g., a protrusion) that
engages a portion (e.g., a recess) of first member 106 of dynamic
interbody device 100'' when the dynamic interbody devices are
positioned between vertebrae. In other embodiments, third member
110 of dynamic interbody device 100' has a portion (e.g., a
protrusion) that engages a portion (e.g., a recess) of first member
110 of dynamic interbody device 100'' when the dynamic interbody
devices are positioned between vertebrae.
FIGS. 3-5 are front, side and top views, respectively, of first
member 106 of dynamic interbody device 100' in accordance with one
or more embodiments of the present technique. First member 106 may
include anchor 116 (e.g., a keel or the like), superior surface
118, slot 120, and opening 122. Anchor 116 may reside in an
aperture or recess formed in a vertebra when dynamic interbody
device 100' is positioned in a disc space between vertebrae. Anchor
116 may inhibit undesired movement of dynamic interbody device 100'
relative to the vertebrae. Superior surface 118 of first member 106
may be curved. The curvature of superior surface 118 may complement
a curvature of an inferior surface of the second member of the
dynamic interbody device to allow the dynamic interbody device to
accommodate lateral bending.
First member 106 may include arcuate slot 120. Arcuate slot 120 may
interact with a complementary protrusion of second member 108 to
allow the dynamic interbody device to accommodate axial rotation.
The curvature of superior surface 118 and arcuate slot 120 allows
dynamic interbody device 100' to provide coupled lateral bending
and axial rotation to the vertebrae adjacent to the dynamic
interbody device. In some embodiments, second member 108 may have
an arcuate slot and first member 106 may have a complementary
protrusion.
Arcuate slot 120 and the protrusion of second member 108 may be
dovetailed or include another type of interconnection system that
inhibits non-rotational separation of first member 106 from second
member 108 when the protrusion of the second member is engaged in
slot 120 of the first member. End surfaces 124 of arcuate slot 120
may interact with the end surfaces of the protrusion of second
member 108 to resist shear load applied to dynamic interbody device
100' when the dynamic interbody device is positioned between
vertebrae. End surfaces 124 and the end surfaces of the protrusion
of second member 108 may be guides for lateral bending and axial
rotation of the vertebrae coupled to dynamic interbody device
100'.
First member 106 may include opening 122 in slot 120. A pin may be
positioned in opening 122. The pin may reside in a groove in second
member 108 to define the maximum amount of lateral bending/axial
rotation allowed by dynamic interbody device 100'. In other
embodiments, a pin positioned in an opening in second member 108
may reside in a groove in first member 106 to define the maximum
amount of lateral bending/axial rotation allowed by dynamic
interbody device 100'.
FIGS. 6-10 are front, side, top, bottom and perspective views,
respectively of second member 108 of dynamic interbody device 100'
in accordance with one or more embodiments of the present
technique. Second member 108 may include inferior surface 126,
recessed surface 128, superior surface 130, protrusion 132, bearing
134, tabs 136, groove 138, and portion 112. Some of inferior
surface 126 may rest on superior surface 118 of first member 106
when protrusion 132 is placed in the arcuate slot 120 of the first
member. Inferior surface 126 may include a curvature that
complements the curvature of superior surface 118 of first member
106 and protrusion 132 may complement the arcuate slot in the first
member so that dynamic interbody device 100' is able to accommodate
coupled lateral bending and axial rotation of the vertebra joined
to the dynamic interbody device.
Portion 112 of second member 108 of dynamic interbody device 100'
(shown in FIGS. 1 and 6) may engage a complementary portion of
second member 108 of second dynamic interbody device 100''
positioned adjacent to dynamic interbody device 100' when dynamic
interbody devices 100', 100'' are positioned in a disc space
between vertebrae. FIG. 10 depicts second member 108 with portion
114 that complements portion 112 of second member shown in FIG. 6.
Engaging portion 112 of dynamic interbody device 100' with
complementary portion 114 of dynamic interbody device 100'' may
stabilize and align the dynamic interbody devices when the dynamic
interbody devices are positioned between vertebrae. Coupling and
aligning dynamic interbody devices 100', 100'' together with
portions 112, 114 may assure that the second members of the dynamic
interbody devices move in tandem relative to the first members of
the dynamic interbody devices.
Coupling dynamic interbody devices 100', 100'' together with
portions 112, 114 may inhibit migration of the dynamic interbody
devices and/or subsidence of the vertebrae coupled to the dynamic
interbody devices. Having complementary portions may require that a
specific dynamic interbody device be installed prior to the other
dynamic interbody device during an insertion procedure. For
example, the dynamic interbody device with a female connection
portion (i.e., portion 114 in FIG. 10) may need to be installed
first. After insertion, migration and/or removal of the dynamic
interbody devices is only possible by reversing the insertion order
with the two dynamic interbody devices held in the same position as
during insertion (i.e., neutral in axial rotation and lateral
bending while in full flexion). Proper positioning of the two
dynamic interbody devices may be determined by examining the
position of the connected portions using imaging techniques before
removal of the insertion instruments.
As shown in FIG. 7, second member 108 may include bearing 134.
Bearing 134 may fit in a recess of third member 110 to allow the
dynamic interbody device to accommodate flexion and extension of
the vertebra coupled to the dynamic interbody device. Bearing 134
may include tabs 136. Tabs 136 may fit in tracks in third member
110 to inhibit separation of second member 108 from the third
member. To assemble the dynamic interbody device, third member 110
may be coupled to second member 108, and/or second member 108 may
be coupled to first member 106. The first member will inhibit
separation of the third member from the second member even when the
dynamic interbody device is subjected to the maximum amount of
extension.
As shown in FIG. 9, groove 138 may be formed in protrusion 132 of
second member 108. In some embodiments, groove 138 may be open at
one side of second member 108. A pin in opening 112 of first member
106 may reside in groove 138 of the assembled dynamic interbody
device.
Second member 108 may include recessed surface 128 in inferior
surface 126. Recessed surface 128 may allow a portion of second
member 108 to extend over a portion of first member 106 of second
dynamic interbody device 100'' without interference during lateral
bending.
FIG. 11 is a perspective view of third member 110 of dynamic
interbody device 100' in accordance with one or more embodiments of
the present technique. Third member 110 may include recess 140 with
tracks 142. Recess 140 and tracks 142 may complement the bearing
and tabs of the second member.
As shown in FIG. 2, first member 106 of each dynamic interbody
device 100', 100'' may include opening 144. Opening 144 may accept
a complementary portion of another device. Opening 144 may be a
threaded opening or have another type of releasable coupling
mechanism. Opening 144 may be used to releasably couple dynamic
interbody device 100' or 100'' to an insertion instrument used for
placing dynamic interbody device within an intervertebral disc
space. In other embodiments, openings for the insertion instrument
may be located in second member 108 and/or the third member
110.
The dynamic interbody device may include one or more features that
allow the insertion instrument to hold the dynamic interbody device
in a desired position. For example, first member 106 may include
slot 146 and third member 110 may include slot 148. In some
embodiments, slots 146, 148 may include other types of depressions
such as a round hole or elongated slot for accepting a
complementary portion of insertion instrumentation. A portion of
the insertion instrument may be placed in slots 146, 148. The
portion of the insertion instrument that fits in slots 146, 148 may
place the dynamic interbody device in a desired position for
insertion between vertebrae (i.e., neutral axial rotation, neutral
lateral bending, and full flexion). For example, a pin of an
insertion instrumentation placed in both of slots 148 and 146 may
fix realtive rotational/bending/flexion positions of first member
106, second member 108 and/or third member 110 such that they may
be held in a relatively fixed position during insertion into the
intervertebral disc space.
Dynamic interbody devices 100', 100'' may work in conjunction to
allow for coupled lateral bending and axial rotation and/or
flexion/extension of vertebrae 102, 104 the dynamic interbody
devices are positioned between. During an insertion procedure,
careful positioning of the dynamic interbody devices 100', 100''
may be needed to ensure that dynamic interbody device 100' works in
conjunction with dynamic interbody device 100''. In some dynamic
interbody device embodiments, a separation angle of about
30.degree. (i.e., each implant oriented at about 15.degree. from a
center line (See angle 450 of FIG. 24) of endplate of the inferior
vertebra being stabilized) is desired between dynamic interbody
devices 100', 100''. In some dynamic interbody device embodiments,
a separation angle of about 24.degree. (i.e., each implant oriented
at about 12.degree. from a center line (See angle 450 of FIG. 24)
of endplate of the inferior vertebra being stabilized) is desired
between dynamic interbody devices 100', 100''. Other embodiments of
dynamic interbody devices may be designed to operate in conjunction
with each other at other separation angles.
In some embodiments, insertion instruments may allow insertion of
dynamic interbody devices 100', 100'' so that ends of the dynamic
interbody devices touch. Intra-operative imaging may be used to
ensure the proper positioning and alignment of the dynamic
interbody devices. In some embodiments, a portion of dynamic
interbody device 100' may engage a portion of dynamic interbody
device 100'' to ensure proper positioning of the dynamic interbody
devices 100', 100''. For example, a dovetailed portion of dynamic
interbody device 100' fits in a complementary groove of dynamic
interbody device 100'' when the dynamic interbody devices are
properly positioned. Engaging dynamic interbody devices may inhibit
migration of the dynamic interbody devices after insertion.
The superior surface of the dynamic interbody device may be coupled
to an upper vertebra of the vertebrae to be stabilized. An inferior
surface of the dynamic interbody device may be coupled to the
inferior vertebra of the vertebrae to be stabilized. At least a
portion the superior surface may be positioned near the edge of the
endplate of the upper vertebra so that the dynamic interbody device
abuts strong, supportive bone of the upper vertebra. At least a
portion of the inferior surface may be positioned near the edge of
the endplate of the inferior vertebra so that the dynamic interbody
device abuts strong, supportive bone of the inferior vertebra.
Dynamic posterior stabilization systems may be used to support
vertebrae and/or to provide resistance to motion of a first
vertebra relative to a second vertebra. FIG. 12 is a perspective
view of a posterior stabilization system 200 in accordance with one
or more embodiments of the present technique. Posterior
stabilization system 200 may be an in-line dynamic posterior
stabilization system 200. Dynamic posterior stabilization system
200 may include first bone fastener 202, second bone fastener 204,
and dampener system 206. Embodiments of a dynamic posterior
stabilization system are further described in U.S. Patent
Publication No. 2009/0105829 to Gimbel et al.
FIG. 13 is a side view of dynamic interbody device 100 and
posterior stabilization system 200 positioned between vertebrae
102, 104 in accordance with one or more embodiments of the present
technique.
Dynamic posterior stabilization system 200 may share a portion of
the load applied to vertebrae 102, 104 while providing guidance and
resistance to flexion/extension and/or lateral bending that is, or
is approximate to, the resistance provided by a normal functional
spinal unit. Allowing for movement of the dynamic interbody device
and for movement of the dynamic posterior stabilization system may
inhibit deterioration of adjacent functional spinal units.
Bridge 300 may be coupled to second bone fastener 204 of dynamic
posterior stabilization system 200. Bridge 300 may inhibit
undesired migration of dynamic interbody device 100 relative to
vertebrae 102, 104 while still allowing for flexion, extension,
lateral bending, and/or axial rotation of the vertebrae. Bridge 300
may couple dynamic interbody device 100 to dynamic posterior
stabilization system 200. Bridge 300 may be coupled to dynamic
posterior stabilization system 200 at or near to second bone
fastener 204. Coupling bridge 300 to dynamic posterior
stabilization system 200 at or near to second bone fastener 204 may
inhibit or eliminate contact of the bridge with neural structure
exiting from between the vertebrae. In some embodiments, a bridge
may not be provided.
In some embodiments, a posterior approach may be used to install a
stabilization system for a patient. The stabilization system may
replace one or more parts of a functional spinal unit of the
patient. The stabilization system may include one or more dynamic
interbody devices, and one or more dynamic posterior stabilization
systems.
A discectomy may provide a disc space between two vertebrae in
which one or more interbody devices may be implanted. In some
embodiments, after a discectomy, two implant trials may be inserted
into the disc space between the vertebrae. The implant trials may
facilitate proper insertion of one or more dynamic interbody
devices into the disc space. For example, the implant trials may be
used to properly align and position the dynamic interbody devices
within the disc space. Additionally, the implant trials may be used
to separate or distract the vertebrae to allow insertion of the
dynamic interbody devices into the disc space. The implant trials
may be inserted on opposite sides of the sagittal plane of the
vertebrae. The implant trial used on one side of the sagittal plane
may be a minor image of the implant trial used on the other
side.
FIGS. 14-18 depict various views of an implant trial 400 in
accordance with one or more embodiments of the present technique.
Implant trial 400 may include elongated body 402, base plate 404,
and nerve root shield 406. Nerve root shield 406 may include
elongated portion 406a and shielding portion 406b. During use, when
the implant trial 400 is inserted into the disc space, shielding
portion 406b may be located superiorly to base plate 404. Nerve
root shield 406 may abut portions of the vertebra during insertion.
For example, shielding portion 406b may about an end plate of the
vertebrae and shielding portion 406a may contact a posterior edge
portion of the vertebrae proximate the endplate as implant trial
400 is advanced into the intervertebral space adjacent the
vertebrae. Nerve root shield 406 may inhibit contact of other
portions (e.g., body 402) with the vertebrae.
Elongated body 402 may be any physical structure, having more
length than width, capable of at least partially supporting another
object. Additionally, elongated body 402 may have any suitable
shape. For example, in the illustrated embodiment, elongated body
402 includes a combination of straight and curved surfaces.
Elongated body 402 may include key 408, slot 410, pin catch 412,
channel/groove 414, and aperture 416. Key 408 may ensure that only
a proper guide member can be used in association with the implant
trial 400. For example, key 408 may have an external shape that is
complementary to an internal shape of the proper (e.g., right or
left) guide member. Slot 410 may be located between a portion of
elongated body 402 and elongated portion 406a of nerve root shield
406. During use, a dilator may be inserted through slot 410
(thereby coupling the dilator to the implant trial) to distract the
disc space. Pin catch 412 may form a portion of a locking
mechanism. Pin catch 412 in conjunction with one or more other
portions of the locking mechanism may couple implant trial 400 to
the guide member and fix the position of the implant trial relative
to the guide member (and vice versa). For example, pin catch 412
may receive a complementary biased stop pin of the proper guide
member. Channel/groove 414 may extend from the distal end of
elongated body 402 to the proximal end of elongated body 402.
Channel/groove 414 may be substantially parallel to a longitudinal
axis of body 402. A drill bit or other type of cutting tool (e.g.,
an end mill, countersink, or reamer) may be inserted through
channel/groove 414 to form an aperture in the inferior vertebra for
accommodating the anchor of a dynamic interbody device. Aperture
416 may extend laterally through elongated body 402 when the
implant trial 400 is inserted into the disc space. In some
embodiments, aperture 416 may be perpendicular or oblique to a
longitudinal axis of body 402. In some embodiments, a true lateral
image of the implant trial 400 may be achieved by aligning imaging
equipment with aperture 416.
Base plate 404 may be coupled to elongated body 402. Base plate 404
may include inferior surface 404a and superior surface 404b.
Inferior surface 404a may have a shape that is substantially the
same as the shape of an inferior surface of a dynamic interbody
device (e.g., inferior surface of first member 106 of dynamic
interbody device 100'). Base plate 404 may further include x-ray
visible features 418 and 420. The location of x-ray visible feature
418 within the disc space may correspond to the approximate
location of the anterior edge of a dynamic interbody device when
the device is inserted into the disc space in place of base plate
404. That is, x-ray visible feature 418 may indicate the
approximate expected location of the anterior edge of the dynamic
interbody device being inserted subsequent to positioning of
implant trial. For example, if base plate 404, coupled to elongated
body 402, is removed from the disc space and the dynamic interbody
device, coupled to the insertion member of an insertion instrument,
is inserted into the disc space via the same guide member as base
plate 404, then the anterior edge of the dynamic interbody device
may be located at approximately the same anterior-posterior depth
within the disc space as was x-ray visible feature 418. Similarly,
x-ray visible feature 420 may indicate the approximate expected
location of the center of rotation of the dynamic interbody device.
Thus, advantageously, the dynamic interbody device may be inserted
between the vertebrae in proper alignment by correctly positioning
the x-ray visible features of base plate 404 within the disc space.
In some embodiments, implant trial 400 may include one or more
additional features that are visible via intra-operative techniques
(e.g., x-ray, computed tomography, ultrasound, and magnetic
resonance imaging).
In some embodiments, one or more dilators 422 may be used to
distract the disc space. FIGS. 17 and 18 are perspective and side
views, respectively, of implant trial 400 including dilator 422 in
accordance with one or more embodiments of the present technique.
As depicted in FIGS. 17 and 18, one or more dilators 422 may be
positioned between base plate 404 and nerve root shield 406 to
facilitate separation of the vertebrae. In some embodiments, with a
leading end of insertion instrument 400 disposed in a vertebral
space between adjacent vertebra, insertion of dilator 422 may
spread inferior and superior surfaces of base plate 404 and nerve
root shield 406 apart, thereby engaging the end plates of the
vertebrae and distracting the vertebrae apart from one another.
Distraction may increase the distance between the two vertebra to
facilitate subsequent insertion of one or more dynamic interbody
devices (e.g., dynamic interbody devices 100' and 100'') within the
disc space. For example, distraction may be conducted to a distance
that is about the same or greater than a height of the dynamic
interbody device to be implanted. Dilator 422 may include proximal
portion 422a, elongated portion 422b, and distal portion 422c.
Proximal portion 422a of dilator 422 may have an inferior and/or
superior surface with a shape that is substantially the same as the
shape of an inferior and/or superior surface of a dynamic interbody
device. Dilator 422 may be releasably coupled to elongated body 402
to distract the disc space. For example, in the illustrated
embodiment, dilator 422 is inserted through slot 410 of elongated
body 402 such that the proximal portion 422a of the dilator is
located between an inferior/superior surface of base plate 404 and
a superior/interior surface of shielding portion 406b of nerve root
shield 406. During use, dilator 422 may be uncoupled from elongated
body 402 and replaced with another dilator. For example, dilator
422 may be extracted from slot 410 of elongated body 402. Dilator
422 may include lip 424 and x-ray visible feature 426. Lip 424 may
limit insertion of dilator 422 through slot 410. For example, in
the illustrated embodiment, lip 424 may be located proximate distal
end 422c of dilator 422 and may engage a complementary portion of
elongated body 402, thereby preventing over-insertion of dilator
422 between base pate 404 and shielding portion 406, and the disc
space. X-ray visible feature 426 may indicate the approximate
expected location of the posterior edge of the dynamic interbody
device. In some embodiments, x-ray visible feature 426 is
radio-opaque. In some embodiments, dilator 422 may include one or
more additional features that are visible via intra-operative
techniques (e.g., x-ray, computed tomography, ultrasound, and
magnetic resonance imaging).
When dilator 422 is positioned in slot 410, shielding portion 406b
of nerve root shield 406 may be pressed against the end plate of
the superior vertebra. Shielding portion 406b may protect the nerve
root of the superior vertebra during the insertion of dilator 422.
For example, shielding portion 406b may inhibit chafing of the
nerve root by preventing direct contact between dilator 422 and the
nerve root. In some embodiments, a surface of shielding portion
406b is shaped substantially complementary to a surface of the
superior vertebra. Additionally, shielding portion 406b may have a
superior surface with a shape that is substantially the same as the
shape of a superior surface of the dynamic interbody device to be
inserted in its place.
A guide frame 428 may couple two implant trials to one another
during use, thereby fixing the positions of the implant trials
relative to one another during use. Fixing the implant trials
realtive to one another may help to ensure that the dynamic
interbody devices are disposed in desired positions relative to one
another. FIG. 19 is a perspective view of guide frame 428 in
accordance with one or more embodiments of the present technique.
Guide frame 428 may include guide members 430, and insertion bridge
432 coupling the guide members. Insertion bridge 432 may include
handle portion 432a and coupling portion 432b. Handle portion 432a
may provide for grasping and manipulation of guide frame 428 by a
user. Coupling portion 432b may provide for coupling of guide
members 430 and instrumentation thereto.
Guide members 430 may be coupled to insertion bridge 432 such that
the guide members are positioned at a selected convergent angle
relative to one another. In various embodiments, guide members 430
are rigidly coupled to one another during use via coupling of each
of guide members 430 to portion 432b of insertion bridge 432. In
some embodiments, the convergent angle is about 45.degree. between
longitudinal axes of the guide members, or about 22.5.degree. from
a midline axis of insertion bridge 432. In some embodiments, the
convergent angle is about 20.degree. to 30.degree. between
longitudinal axes of the guide members, or about 10.degree. to
15.degree. from a midline axis of insertion bridge 432. In certain
embodiments, the convergent angle is about 24.degree. between
longitudinal axes of the guide members, or about 12.degree. from a
midline axis of insertion bridge 432. In some embodiments, the
position of one guide member is substantially mirrored by the other
guide member. That is, the guide members are equally angled from a
midline axis of insertion bridge 432.
Guide member 430 may include guide 434 and guide release 436. FIGS.
20 and 21 are top views of guide member 430 with guide release 436
in a first (locked) position and a second (unlocked) position,
respectively, in accordance with one or more embodiments of the
present technique. The internal shape of guide 434 may define an
opening 434a. Opening 434a may be of any suitable shape or size.
For example, in the illustrated embodiment, opening 434a includes a
channel having a lateral opening. In some embodiments, opening 434a
includes a laterally enclosed passage having a longitudinal
opening. Opening 434a may be complementary to the external shape of
a key of the proper corresponding implant trial or insertion
instrument. As such, opening 434a may guide longitudinal movement
of the implant trial or insertion instrument relative to guide
frame 428. For example, the elongated body of an implant trial or
insertion instrument may slide longitudinally through opening 434a
of guide 434.
Guide release 436 may include grip 438 and stop pin 440. Stop pin
440 may form a portion of a locking mechanism. Stop pin 440 in
conjunction with one or more other of the locking mechanism may
couple implant trial 400 to guide member 430 and fix the position
of the implant trial relative to guide member 430. For example,
stop pin 440 may protrude into the complementary pin catch of an
implant trial 400. In a first (locked) position (depicted in FIG.
20), stop pin 440 may extend laterally into opening 434a of guide
434. For example, a spring or other bias member (not shown) may
urge stop pin 440 into opening 434a. In a second (unlocked)
position (depicted in FIG. 21), stop pin 440 may be pulled out of
opening 434a via grip 438. With pin 440 in the unlocked position,
implant trial 400 or similar instrumentation may be able to slide
longitudinally though opening 434a, whereas, with pin 440 in the
locked position, the implant trial 400 or similar instrumentation
may be inhibited from sliding longitudinally though opening
434a
FIG. 22 is a perspective view of an insertion instrument 500 in
accordance with one or more embodiments of the present technique.
In some embodiments, two cooperative dynamic interbody devices may
be inserted between the vertebrae using one or more insertion
instruments 500. For example, each of the dynamic interbody devices
may be releasably coupled to a respective insertion instrument. In
some embodiments, subsequent to distraction of the intervertebral
space via the above described techniques, a first of the implant
trials 400 is removed from opening 434a of guide frame 428 and
replaced with a first insertion instrument 500 having a first
dynamic interbody device coupled thereto, followed by a second of
the implant trials 400 being removed from the other opening 434a of
guide frame 428 and replaced with a second insertion instrument 500
having a second dynamic interbody device coupled thereto. In some
embodiments, the insertion instrument for the second dynamic
interbody device may be a minor image of the insertion instrument
for the first dynamic interbody device.
Insertion instrument 500 may include elongated body 502, insertion
member 504, wheel 506, and insert(s) 507. Elongated body 502 may
include key 508, pin catch 510, passageway 512, and
ridge/protrusion 514. Key 508 may ensure that only the proper guide
member can be used in association with the particular insertion
instrument. For example, key 508 may have an external shape that is
complementary to the internal shape (e.g., shape of opening 434a)
of the proper guide member. In some embodiments, the proper guide
member for the insertion instrument 500 may be the same guide
member used in conjunction with implant trial 400. For example, the
external shape of key 508 of insertion instrument 500 may be
substantially the same as the external shape of key 408 of implant
trial 400. Pin catch 510 may form a portion of a locking mechanism.
Pin catch 510 in conjunction with one or more other portions of the
locking mechanism may couple the insertion instrument to the guide
member and fix the position of the insertion instrument relative to
the guide member. For example, pin catch 510 may receive a
complementary biased stop pin of the proper guide member. Insert
507 may provide for the adjustment of a height/thickness of
insertion instrument 500 to match a specific height implant. For
example, the illustrated embodiment, insert 507 labeled "12 mm" is
designed for use with a 12 mm implant (e.g., interbody device 100',
100'').
Insertion member 504 may be coupled to elongated body 502 of
insertion instrument 500. For example, in the illustrated
embodiment, insertion member 504 may be positioned within
passageway 512 of elongated body 502. In some embodiments,
insertion member 504 is telescopically coupled to elongated body
502. For example, in the illustrated embodiment, wheel 506 may be
rotated to rotate insertion member 504. Rotating insertion member
504 may advance or retract the insertion member relative to the
elongated body 502 of insertion instrument 500.
In some embodiments, insertion member 504 is provided with a
substantially circular cross-section. For example, in the
illustrated embodiment, insertion member 504 includes a cylindrical
rod shaped member. Insertion member 504 may include a distal end
504a and a proximal end 504b. Distal end 504a of insertion member
504 may be coupled to wheel 506. Proximal end 504b of insertion
member 504 may protrude from the proximal end of elongated body
502. Proximal end 504b of insertion member 504 may be threaded. An
appropriate dynamic interbody device may be releasably coupled to
insertion member 504. For example, proximal end 504b of insertion
member 504 may mate with a threaded opening in the appropriate
dynamic interbody device. Further, when proximal portion 504b of
insertion member 504 is threaded to the appropriate dynamic
interbody device, ridge 514 may reside in a corresponding slot of
the dynamic interbody device to place the dynamic interbody device
in the desired position for insertion (i.e., neutral axial
rotation, neutral lateral bending, and full flexion).
FIGS. 23-36 illustrate a sequence of steps for inserting a dynamic
interbody device into a disc space. FIG. 37 is a flowchart that
illustrates a method 600 of inserting a dynamic interbody device
into a disc space in accordance with one or more embodiments of the
present technique. Although several embodiments are discussed with
regard to dynamic interbody devices, the same or similar techniques
may be employed for inserting other types of implants, such as
spinal fusion implants. For example, the illustrated method may
also be used for inserting one or more non-dynamic interbody
devices (e.g., a pair of fusion interbody) into a disc space.
Method 600 may generally include inserting a base plate of an
implant trial into an intervertebral disc space; inserting one or
more dilators into the disc space to achieve distraction of the
disc space; removing the base plate and dilators from the disc
space; and inserting the interbody device into the disc space in
substantially the same position as the base plate.
In some embodiments, method 600 includes inserting a base plate of
an implant trial into an intervertebral disc space, as depicted at
block 602. Initially, when a dilator is not coupled to the
elongated body (see FIG. 23), the implant trial may have a
distraction height that is less than the separation height of the
vertebrae, thereby allowing for insertion of base plate 404' into
the disc space between vertebrae 104 and vertebrae 102 (not
depicted in FIG. 23 for clarity). The distraction height may be
measured as the distance between inferior surface 404a' of base
plate 404' and the superior surface of shielding portion 406b' of
nerve root shield 406'. The separation height 480 may be measured
as the distance between the superior surface of inferior vertebra
104 and the inferior surface of superior vertebra 102 (see FIG.
26).
Base plate 404' of implant trial 400' may be selectively inserted
and positioned at least partially within the disc space. For
example, in the illustrated embodiment, base plate 404' is
positioned at a selected anterior-posterior depth 444 (see FIG.
24). In some embodiments, base plate 404' may be inserted into the
disc space until x-ray visible feature 418' is positioned at a
selected distance from the anterior edge 104a of inferior vertebra
104. In some embodiments, base plate 404' may be inserted into the
disc space substantially through a region bordered by the vertebral
endplates, dura, and exiting nerve root (not shown) of the
vertebrae. Base plate 404' may be positioned against the superior
surface of inferior vertebra 104. Base plate 404' may be positioned
within the disc space at a selected angle 450 with respect to the
sagittal plane 452. In some embodiments, the selected angle is
between about 10.degree. to 14.degree.. In certain embodiments, the
selected angle is about 12.degree.. Base plate 404' may be
positioned within the disc space such that a portion of the base
plate is on or near the sagittal plane. Positioning of base plate
404' may be confirmed by locating x-ray visible features 418',
420', and/or an additional feature of base plate 404' via
intra-operative (e.g., x-ray, computed tomography, ultrasound, and
magnetic resonance imaging). In some embodiments, lateral imaging
techniques may be used to confirm that anterior-posterior depth of
base plate 404'. Intra-operative equipment may be aligned with
aperture 416' of implant trail 400' to obtain a true lateral image
of the implant trial within the disc space.
In some embodiments, method 600 includes inserting one or more
dilators to the disc space to achieve distraction of the disc
space, as depicted at block 604. Proximal portion 422a' of dilator
422' may be inserted between the vertebrae to distract the disc
space. For example, in the illustrated embodiment, dilator 422' may
be removably inserted into slot 410' of implant trial 400' (see
FIG. 25). Dilator 422' may be inserted into slot 410' until lip
424' is engaged with a portion of elongated body 402'. The height
of dilator 422' may be such that shielding portion 406b' of nerve
root shield 406' is pressed against the inferior face of superior
vertebra 102 (see FIG. 26). X-ray visible feature 426' may be
located less than about 5 millimeters (about 0.196 inches) from the
posterior vertebral body edge 104b of inferior vertebra 104. The
position of dilator 422' may be verified by locating x-ray visible
feature 426' and/or an additional feature of dilator 422' via
intra-operative (e.g., x-ray, computed tomography, ultrasound, and
magnetic resonance imaging).
Guide member 430' of guide frame 428 may be placed proximate
implant trial 400'. Guide member 430' may be coupled to implant
trial 400'. For example, in the illustrated embodiment, grip 438'
of guide release 436' may be pulled outwards to withdraw a stop pin
from opening 434a' of guide 434'; guide 434' may then be engaged
with key 408' of elongated body 402' (see FIG. 27). In some
embodiments, guide 434' is laterally engaged with key 408'. In some
embodiments, guide 434' is longitudinally engaged with key 408'.
Grip 438' may be released so that a spring in guide release 436'
urges the stop pin against key 408'. Once engaged, guide member
430' may be lowered along key 408' until the stop pin extends into
pin catch 412'. In some embodiments, elongated body 402' is
slidable through opening 434a' of guide 434'.
Implant trial 400'' may be placed proximate second guide member
430'' of guide frame 428 (see FIG. 28). Implant trial 400'' may be
coupled to guide member 430''. For example, in the illustrated
embodiment, grip 438'' of guide release 436'' may be pulled
outwards to withdraw a stop pin from opening 434a'' of guide 434'';
key 408'' may then be engaged with guide 434''. In some
embodiments, key 408'' is laterally engaged with guide 434''. In
some embodiments, key 408'' is longitudinally engaged with guide
434''. Grip 438'' may be released so that a spring in guide release
436'' urges the stop pin against key 408''. Once engaged, implant
trial 400''may be lowered along guide 434'' until the stop pin
extends into pin catch 412''. In some embodiments, elongated body
402'' is slidable through opening 434a'' of guide 434''.
The position of base plate 404'' within the disc space may
substantially minor the position of base plate 404' within the disc
space. As such, a portion of base plate 404'' may abut or be close
to abutting the portion of base plate 404' on or near the sagittal
plane 452 (see FIG. 29). Angle 458 between the abutting portions of
base plates 404' and 404'' may be equal to the convergent angle of
the guide members. In some embodiments, angle 458 is about
20.degree. to 30.degree.. In certain embodiments, angle 458 is
about 24.degree.. In some embodiments, the base plates of the
expandable trials may be coupled together with male and female
portions when the base plates are positioned between the vertebrae.
In some embodiments, base plates 404' and 404'' are positioned at a
selected, substantially equal anterior-posterior depth 444.
Positioning of base plates 404', 404'' may be confirmed via
intra-operative (e.g., x-ray, computed tomography, ultrasound, and
magnetic resonance imaging).
The proximal portion of a second dilator may be inserted between
the vertebrae to further distract the disc space. For example, the
second dilator may be removably inserted into slot 410'' of implant
trial 400''. The height of the second dilator may be such that
shielding portion 406b'' of nerve root shield 406'' is firmly
pressed against the inferior face of superior vertebra 102. The
dilators inserted into the disc space may be sequentially removed
and replaced one after the other with progressively larger dilators
until a maximum separation height is achieved. A maximum separation
height may be achieved when the disc space opens posteriorly
without parallel anterior separation. The separation height 480
between the vertebrae may be verified via lateral x-ray imaging. In
some embodiments, the size of a dynamic interbody device to be
implanted within the disc space is determined according to the
maximum separation height. In some embodiments, a height of the
interbody device is less than or equal to the maximum separation
height achieved via distraction. For example, the height of a
dynamic interbody device may be about 2 millimeters (about 0.079
inches) or less than the maximum separation height achieved via
distraction.
A drill guide 460' may be positioned in a groove of implant trial
400' (see FIG. 30). Drill guide 460' may include flag 462' and
tubular body 464'. The proximal end of drill guide 460' may abut
the posterior vertebral body edge 104b of inferior vertebra 104.
Flag 462' may be located at the distal end of the drill guide. The
distance 466 between flag 462' and a surface of elongated body 402'
may indicate the approximate expected distance between the
posterior end of the dynamic interbody device and the posterior
vertebral body edge 104b of inferior vertebra 104.
A anchor guide 468' may be inserted through tubular body 464' of
drill guide 460' to form an aperture in inferior vertebra 104 for
the anchor of the dynamic interbody device (see FIG. 31). Anchor
guide 468' may include shaft 470', drill bit 472', and drill stop
474'. Shaft 470' may extend drill bit 472' through tubular body
464' and into the disc space. Drill bit 472' may pierce the
vertebral body of the inferior vertebra 104, thereby forming an
aperture (see FIG. 32) in the inferior vertebra. Drill stop 474',
located near the distal end of the anchor guide, may abut a portion
of elongated body 402 to prevent boring of the vertebral body
passed a selected depth. Similar drill and anchor guides may be
used in conjunction with implant trial 400'' to form a second
aperture in the vertebral body of the inferior vertebra 104.
In some embodiments, method 600 removing the base plate and
dilators from the disc space, as depicted at block 606. A dilator
may be removed from the disc space and slot 410'' to decrease the
distraction height of implant trial 400''. Implant trial 400'' may
be uncoupled from guide member 430'' of guide frame 428. For
example, in the illustrated embodiment, grip 438'' of guide release
436'' may be pulled outwards to withdraw the stop pin from guide
434''. Implant trial 400'' may then be removed from the disc space
and guide member 430''. Base plate 404'' of implant trial 400'' may
be removed from the disc space while base plate 404' of implant
trial 400' remains at least partially inserted in the disc space
(see FIG. 33).
In some embodiments, method 600 includes inserting the interbody
device into the disc space in substantially the same position as
the base plate, as depicted at block 608. Insertion instrument
500'' coupled to dynamic interbody device 100'' may be placed
proximate guide member 430'' of guide frame 428. Elongated body
502'' of insertion instrument 500'' may be coupled to guide member
430''. For example, in the depicted embodiment, grip 438'' of guide
release 436'' may be pulled outwards to withdraw the stop pin from
the opening of guide 434''; key 508'' may be engaged with guide
434'' (see FIG. 34). In some embodiments, key 508'' is laterally
engaged with guide 434''. In some embodiments, key 508'' is
longitudinally engaged with guide 434''. Grip 438' may then be
released so that the spring in guide release 436'' urges the stop
pin against key 508''. Once engaged, insertion instrument 500'' may
be lowered through guide 434'' until the stop pin extends into pin
catch 510''. Anchor 116 of dynamic interbody device 100'' may be
received by the aperture formed in inferior vertebra 104. If
needed, a mallet or other impact instrument may be driven against a
distal end of insertion instrument 500'' to drive dynamic interbody
device 100'' between the vertebrae (see FIG. 35).
Implant trial 400' may be removed from the disc space and guide
member 430' of guide frame 428. Insertion instrument 500' coupled
to dynamic interbody device 100' may be inserted in a similar
manner as that described above with respect to insertion instrument
500'' and dynamic interbody device 100''. FIG. 36 depicts insertion
instruments 500', 500'' and dynamic interbody devices 100', 100''
positioned in the disc space. Positioning of dynamic interbody
devices 100', 100'' may be confirmed via intra-operative (e.g.,
x-ray, computed tomography, ultrasound, and magnetic resonance
imaging). In some embodiments, when the dynamic interbody devices
100', 100'' are properly interconnected and positioned, insertion
members 504', 504'' may be uncoupled from the respective portions
of the dynamic interbody devices 100', 100''. For example, in the
illustrated embodiment, wheels 506', 506'' of insertion instruments
500', 500'' may be rotated to withdraw insertion members 504',
504'' from openings 144 of dynamic interbody devices 100', 100''.
Grips 438', 438'' of guide members 430', 430'' may be pulled
outwards to retract the stop pins of the guide releases 436', 436''
from channels 434', 434'', and insertion instruments 500', 500''
may be removed from the disc space and guide members. It will be
appreciated that the above described techniques are illustrative,
and modifications thereto may be within the scope of this
disclosure. For example, in some embodiments, implant trial 400'
may be removed and insertion instrument 500' and dynamic interbody
device 100' may be installed prior to removal of implant trial
400'' and installation of insertion instrument 500'' and dynamic
interbody device 100''. In some embodiments, insertion bridge 428
and/or guide frame 432 may be removed prior to removal of insertion
instruments 500', 500''.
Additional techniques that may be used to insert dynamic interbody
devices between vertebrae are described in U.S. Patent Publication
No. 2009/0105829 to Gimbel et al.
Further modifications and alternative embodiments of various
aspects of the invention will be apparent to those skilled in the
art in view of this description. Accordingly, this description is
to be construed as illustrative only and is for the purpose of
teaching those skilled in the art the general manner of carrying
out the invention. It is to be understood that the forms of the
invention shown and described herein are to be taken as examples of
embodiments. Elements and materials may be substituted for those
illustrated and described herein, parts and processes may be
reversed, and certain features of the invention may be utilized
independently, all as would be apparent to one skilled in the art
after having the benefit of this description of the invention.
Changes may be made in the elements described herein without
departing from the spirit and scope of the invention as described
in the following claims. Furthermore, note that the word "may" is
used throughout this application in a permissive sense (i.e.,
having the potential to, being able to), not a mandatory sense
(i.e., must). The term "include", and derivations thereof, mean
"including, but not limited to". As used throughout this
application, the singular forms "a", "an" and "the" include plural
referents unless the content clearly indicates otherwise. Thus, for
example, reference to "a member" includes a combination of two or
more members. The term "coupled" means "directly or indirectly
connected".
In this patent, certain U.S. patents, and U.S. patent applications
have been incorporated by reference. The text of such U.S. patents
and U.S. patent applications is, however, only incorporated by
reference to the extent that no conflict exists between such text
and the other statements and drawings set forth herein. In the
event of such conflict, then any such conflicting text in such
incorporated by reference U.S. patents and U.S. patent applications
is specifically not incorporated by reference in this patent.
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